CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
busulfan +3 moredrug
Likely dose
Busulfan given PO or IV; etoposide given IV; aldesleukin (IL-2) given SCAI-extracted
Key inclusion· 4
  • ✓AML in first complete remission (CR) with intermediate or high-risk features, defined by: >1 induction cycle needed for CR, WBC >100,000/mm³ at diagnosis, high-risk cytogenetics (inv3, t3:3, del5q/-5, 11q23, del7q/-7, del20q/-20, abnormal 12p, +11, t8), or other abnormalities predicting intermediate/high relapse risk
  • ✓AML beyond first complete remission (CR)
  • ✓Adequate previously collected stem cells: ≥2×10⁸ total nucleated cells (TNC)/kg bone marrow OR ≥4×10⁶ CD34+ peripheral blood stem cells/kg (unless otherwise approved)
  • ✓At least two cycles of consolidation chemotherapy completed after induction therapy prior to stem cell mobilization and transplant
Key exclusion· 10
  • ✕Good-risk AML defined by cytogenetics: inversion 16 or t(8;21)
  • ✕Severely limited life expectancy from diseases other than AML
  • ✕HIV seropositive
  • ✕Pregnant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003875
NCT00003875Phase 2Completed
CompareCT.gov

Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy

Fred Hutchinson Cancer Center·interventional·Posted Jan 27, 2003·Updated Jun 5, 2017

In Brief

A Phase 2 clinical trial evaluating busulfan, etoposide, and 2 other interventions for Adult Acute Myeloid Leukemia in Remission and 7 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects and how well giving busulfan and etoposide followed by peripheral blood stem cell transplant (PBSCT) and low-dose aldesleukin works in treating patients with acute myeloid leukemia (AML). Drugs used in chemotherapy, such as busulfan and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A PBSCT may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more cancer cells are killed. Aldesleukin may stimulate the white blood cells to kill cancer cells. Giving busulfan and etoposide together followed by PBSCT and aldesleukin may be an effective treatment for AML.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Childhood Acute Myeloid Leukemia in Remission, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartOct 13, 1998
Primary CompletionJun 11, 2015
TodayJul 2, 2026
Enrollment to primary: 16.7 yearsPosted 23.4 years ago

Interventions

busulfandrug

Given PO or IV

etoposidedrug

Given IV

aldesleukinbiological

Given SC

peripheral blood stem cell transplantationprocedure

Undergo autologous or syngeneic stem cell rescue